Reduced pressure therapy device operation and authorization monitoring

ABSTRACT

Embodiments of a negative pressure wound therapy systems and methods for operating the systems are disclosed. In some embodiments, a system includes a pump assembly, canister, and a wound dressing configured to be positioned over a wound. The pump assembly, canister, and the wound dressing can be fluidically connected to facilitate delivery of negative pressure to a wound. The pump assembly can be configured to communicate data to a remote computer. The data can include location information, usage information, therapy information, and the like. Remote management and tracking of the pump assembly can be performed.

BACKGROUND Field

Embodiments of the present disclosure relate to methods and apparatusesfor dressing and treating a wound with reduced pressure therapy ortopical negative pressure (TNP) therapy. In particular, but withoutlimitation, embodiments disclosed herein relate to negative pressuretherapy devices, methods for controlling the operation of TNP systems,and methods of using TNP systems.

Description of the Related Art

Many different types of wound dressings are known for aiding in thehealing process of a human or animal. These different types of wounddressings include many different types of materials and layers, forexample, gauze, pads, foam pads or multi-layer wound dressings. Topicalnegative pressure (TNP) therapy, sometimes referred to as vacuumassisted closure, negative pressure wound therapy, or reduced pressurewound therapy, is widely recognized as a beneficial mechanism forimproving the healing rate of a wound. Such therapy is applicable to abroad range of wounds such as incisional wounds, open wounds andabdominal wounds or the like.

TNP therapy assists in the closure and healing of wounds by reducingtissue oedema, encouraging blood flow, stimulating the formation ofgranulation tissue, removing excess exudates and may reduce bacterialload and, thus, infection to the wound. Furthermore, TNP therapy permitsless outside disturbance of the wound and promotes more rapid healing.

SUMMARY

In some embodiments, an apparatus for processing registration and usageinformation for a plurality of negative pressure wound therapy devicesincludes a memory and a computer system including computer hardware. Thememory is configured to store account information for a plurality ofnegative wound pressure therapy devices. The computer system is incommunication with the memory. The computer system is configured to:receive a registration request to register a negative wound pressuretherapy device of the plurality of negative wound pressure therapydevices to an account in the account information, the account associatedwith a user; determine, based at least on the registration request,whether the negative wound pressure therapy device is authorized to beregistered to the account; in response to determining that the negativewound pressure therapy device is not authorized to be registered to theaccount, perform a first exception action; in response to determiningthat the negative wound pressure therapy device is authorized to beregistered to the account, register the negative wound pressure therapydevice to the account so that data gathered by the computer system aboutoperations of the negative wound pressure therapy device is accessiblevia the account; receive a usage notification for the negative woundpressure therapy device, the usage notification indicating a location ofthe negative wound pressure therapy device and an operation performed bythe negative wound pressure therapy device; determine, based at least onthe usage notification, whether the negative wound pressure therapydevice is being operated at an authorized location and whether theoperation performed by the negative wound pressure therapy device is anauthorized operation; in response to determining that the negative woundpressure therapy device is not operated in the authorized location orthat the operation performed by the negative wound pressure therapydevice is not the authorized operation, perform a second exceptionaction; and in response to determining that the negative wound pressuretherapy device is operated in the authorized location and the operationperformed by the negative wound pressure therapy device is theauthorized operation, store in the memory an indication of performanceof the operation by the negative wound pressure therapy device to theaccount.

In some embodiments, the apparatus of the preceding paragraph caninclude one or more of the following features. The computer system canbe configured to receive the registration request from a user system viaa computer network, and the registration request can include a firstaccount identifier corresponding to the account and a first deviceidentifier corresponding to the negative wound pressure therapy device.The computer system can be configured to use a look-up table comprisingaccount identifiers and device identifiers to determine whether thenegative wound pressure therapy device is authorized to be registered tothe account, and the account identifiers can include the first accountidentifier and the device identifiers can include the first deviceidentifier. The first exception action can include generation andtransmission of a notification communication to an owner of the accountor an administrator of a group that includes the account, and thenotification communication can indicate that the negative wound pressuretherapy device was attempted to be registered to the account and thatthe negative wound pressure therapy device is unauthorized to beregistered to the account. The first exception action can includegeneration and transmission of a command message to the negative woundpressure therapy device, and the command message can instruct thenegative wound pressure therapy device not to perform one or moreoperations. The computer system can be configured to receive the usageindication from the negative wound pressure therapy device via acomputer network, and the usage notification can provide the location asa Global Positioning System (GPS) location. The computer system can beconfigured to use a look-up table comprising device identifiers andlocation identifiers to determine whether the negative wound pressuretherapy device is operated at the authorized location, and the deviceidentifiers can include a first device identifier corresponding to thenegative wound pressure therapy device and the location identifiers caninclude a first location identifier corresponding to the authorizedlocation. The computer system can be configured to use a look-up tablecomprising device identifiers and operation identifiers to determinewhether the operation performed by the negative wound pressure therapydevice is the authorized operation, and the device identifiers caninclude a first device identifier corresponding to the negative woundpressure therapy device and the operation identifiers can include afirst operation identifier corresponding to the authorized operation.The second exception action can include generation and transmission of anotification communication to an owner of the account or anadministrator of a group that includes the account, and the notificationcommunication can indicate that the negative wound pressure therapydevice is operated outside of the authorized location. The secondexception action can include generation and transmission of anotification communication to an owner of the account or anadministrator of a group that includes the account, and the notificationcommunication can indicate that the negative wound pressure therapydevice performed an unauthorized operation. The first exception actioncan include generation and transmission of a command message to thenegative wound pressure therapy device, and the command message caninstruct the negative wound pressure therapy device not to perform oneor more operations. The first exception action can be the same as thesecond exception action.

In some embodiments, a method of operating the apparatus of any of thepreceding two paragraphs is disclosed.

In some embodiments, an apparatus for applying negative pressure therapyto a wound is disclosed. The apparatus includes a source of negativepressure and a controller. The source of negative pressure is configuredto be fluidically connected to a dressing configured to be placed over awound. The source of negative pressure is configured to deliver negativepressure wound therapy to the wound. The controller is configured to:control operations of the source of negative pressure; record operationdata indicative of the operations performed by the source of negativepressure; record location data corresponding to geographical locationsof the source of negative pressure over time; transmit to a remotecomputer over a communication interface via a computer network at leastsome of the operation data and at least some of the location data; andvary, based at least on one or more conditions, a timing of at least oneof (i) when the controller records the operation data or the locationdata or (ii) when the controller transmits the at least some of theoperation data and the at least some of the location data.

In some embodiments, the apparatus of the preceding paragraph caninclude one or more of the following features. The one or moreconditions can include one or more of: (i) the controller transitioningfrom a first mode of operation for the source of negative pressure to asecond mode of operation for the source of negative pressure differentfrom the first mode of operation, (ii) the controller connecting to acommunications network, (iii) the source of negative pressure or thecontroller being powered by a mains power source rather than by abattery, (iv) the controller operating in a high power mode rather thana low power mode, (v) a communications network connection being enabledfor the controller, (vi) the source of negative pressure or thecontroller being powered on or powered off, and (vii) data beinggathered to the controller as a result of provision of therapy ratherthan being loaded to the controller from an external connection port ofa housing comprising the source of negative pressure and the controller.

In some embodiments, a method of operating the apparatus of any of thepreceding two paragraphs is disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure will now be described hereinafter,by way of example only, with reference to the accompanying drawings inwhich:

FIG. 1 illustrates a reduced pressure wound therapy system according tosome embodiments.

FIGS. 2A-2C illustrate a pump assembly and canister according to someembodiments.

FIG. 3 illustrates an electrical component schematic of a pump assemblyaccording to some embodiments.

FIG. 4 illustrates a system schematic according to some embodiments.

FIGS. 5A-5C illustrate graphical user interface screens according tosome embodiments.

FIG. 6 illustrates a process for validating the registration and usageof a pump assembly with a remote server according to some embodiments.

DETAILED DESCRIPTION OF SOME EMBODIMENTS

Overview

Embodiments disclosed herein relate to systems and methods of treating awound with reduced pressure. As is used herein, reduced or negativepressure levels, such as −X mmHg, represent pressure levels relative tonormal ambient atmospheric pressure, which can correspond to 760 mmHg(or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.) Accordingly, anegative pressure value of −X mmHg reflects absolute pressure that is XmmHg below 760 mmHg or, in other words, an absolute pressure of (760−X)mmHg. In addition, negative pressure that is “less” or “smaller” than XmmHg corresponds to pressure that is closer to atmospheric pressure(e.g., −40 mmHg is less than −60 mmHg). Negative pressure that is “more”or “greater” than −X mmHg corresponds to pressure that is further fromatmospheric pressure (e.g., −80 mmHg is more than −60 mmHg). In someembodiments, local ambient atmospheric pressure is used as a referencepoint, and such local atmospheric pressure may not necessarily be, forexample, 760 mmHg.

Embodiments of the present disclosure are generally applicable to use intopical negative pressure (TNP) or reduced pressure therapy systems.Briefly, negative pressure wound therapy assists in the closure andhealing of many forms of “hard to heal” wounds by reducing tissueoedema, encouraging blood flow and granular tissue formation, and/orremoving excess exudate and can reduce bacterial load (and thusinfection risk). In addition, the therapy allows for less disturbance ofa wound leading to more rapid healing. TNP therapy systems can alsoassist in the healing of surgically closed wounds by removing fluid. Insome embodiments, TNP therapy helps to stabilize the tissue in theapposed position of closure. A further beneficial use of TNP therapy canbe found in grafts and flaps where removal of excess fluid is importantand close proximity of the graft to tissue is required in order toensure tissue viability.

Negative Pressure System

FIG. 1 illustrates an embodiment of a negative or reduced pressure woundtreatment (or IMP) system 100 comprising a wound filler 130 placedinside a wound cavity 110, the wound cavity sealed by a wound cover 120.The wound filler 130 in combination with the wound cover 120 can bereferred to as wound dressing. A single or multi lumen tube or conduit140 is connected the wound cover 120 with a pump assembly 150 configuredto supply reduced pressure. The wound cover 120 can be in fluidiccommunication with the wound cavity 110. In any of the systemembodiments disclosed herein, as in the embodiment illustrated in FIG.1, the pump assembly can be a canisterless pump assembly (meaning thatexudate is collected in the wound dressing or is transferred via tube140 for collection to another location). However, any of the pumpassembly embodiments disclosed herein can be configured to include orsupport a canister. Additionally, in any of the system embodimentsdisclosed herein, any of the pump assembly embodiments can be mounted toor supported by the dressing, or adjacent to the dressing. The woundfiller 130 can be any suitable type, such as hydrophilic or hydrophobicfoam, gauze, inflatable bag, and so on. The wound filler 130 can beconformable to the wound cavity 110 such that it substantially fills thecavity. The wound cover 120 can provide a substantially fluidimpermeable seal over the wound cavity 110. The wound cover 120 can havea top side and a bottom side, and the bottom side adhesively (or in anyother suitable manner) seals with wound cavity 110. The conduit 140 orlumen or any other conduit or lumen disclosed herein can be formed frompolyurethane, PVC, nylon, polyethylene, silicone, or any other suitablematerial.

Some embodiments of the wound cover 120 can have a port (not shown)configured to receive an end of the conduit 140. In other embodiments,the conduit 140 can otherwise pass through and/or under the wound cover120 to supply reduced pressure to the wound cavity 110 so as to maintaina desired level of reduced pressure in the wound cavity. The conduit 140can be any suitable article configured to provide at least asubstantially sealed fluid flow pathway between the pump assembly 150and the wound cover 120, so as to supply the reduced pressure providedby the pump assembly 150 to wound cavity 110.

The wound cover 120 and the wound filler 130 can be provided as a singlearticle or an integrated single unit. In some embodiments, no woundfiller is provided and the wound cover by itself may be considered thewound dressing. The wound dressing may then be connected, via theconduit 140, to a source of negative pressure, such as the pump assembly150. The pump assembly 150 can be miniaturized and portable, althoughlarger conventional pumps can also be used.

The wound cover 120 can be located over a wound site to be treated. Thewound cover 120 can form a substantially sealed cavity or enclosure overthe wound site. In some embodiments, the wound cover 120 can beconfigured to have a film having a high water vapour permeability toenable the evaporation of surplus fluid, and can have a superabsorbingmaterial contained therein to safely absorb wound exudate. It will beappreciated that throughout this specification reference is made to awound. In this sense it is to be understood that the term wound is to bebroadly construed and encompasses open and closed wounds in which skinis torn, cut or punctured or where trauma causes a contusion, or anyother surficial or other conditions or imperfections on the skin of apatient or otherwise that benefit from reduced pressure treatment. Awound is thus broadly defined as any damaged region of tissue wherefluid may or may not be produced. Examples of such wounds include, butare not limited to, acute wounds, chronic wounds, surgical incisions andother incisions, subacute and dehisced wounds, traumatic wounds, flapsand skin grafts, lacerations, abrasions, contusions, burns, diabeticulcers, pressure ulcers, stoma, surgical wounds, trauma and venousulcers or the like. The components of the TNP system described hereincan be particularly suited for incisional wounds that exude a smallamount of wound exudate.

Some embodiments of the system are designed to operate without the useof an exudate canister. Some embodiments can be configured to support anexudate canister. In some embodiments, configuring the pump assembly 150and conduit 140 so that the conduit 140 can be quickly and easilyremoved from the pump assembly 150 can facilitate or improve the processof dressing or pump changes, if necessary. Any of the pump embodimentsdisclosed herein can be configured to have any suitable connectionbetween the tubing and the pump.

In some embodiments, the pump assembly 150 can be configured to delivernegative pressure of approximately −80 mmHg, or between about −20 mmHgand −200 mmHg. Note that these pressures are relative to normal ambientatmospheric pressure thus, −200 mmHg would be about 560 mmHg inpractical terms. The pressure range can be between about −40 mmHg and−150 mmHg. Alternatively a pressure range of up to −75 mmHg, up to −80mmHg or over −80 mmHg can be used. Also a pressure range of below −75mmHg can be used. Alternatively a pressure range of over approximately−100 mmHg, or even 150 mmHg, can be supplied by the pump assembly 150.

In some embodiments, the pump assembly 150 is configured to providecontinuous or intermittent negative pressure therapy. Continuous therapycan be delivered at above −25 mmHg, −25 mmHg, −40 mmHg, −50 mmHg, −60mmHg, −70 mmHg, −80 mmHg, −90 mmHg, −100 mmHg, −120 mmHg, −140 mmHg,−160 mmHg, −180 mmHg, −200 mmHg, or below −200 mmHg. Intermittenttherapy can be delivered between low and high negative pressuresetpoints. Low setpoint can be set at above 0 mmHg, 0 mmHg, −25 mmHg,−40 mmHg, −50 mmHg, −60 mmHg, −70 mmHg, −80 mmHg, −90 mmHg, −100 mmHg,−120 mmHg, −140 mmHg, −160 mmHg, −180 mmHg, or below −180 mmHg. Highsetpoint can be set at above −25 mmHg, −40 mmHg, −50 mmHg, −60 mmHg, −70mmHg, −80 mmHg, −90 mmHg, −100 mmHg, −120 mmHg, −140 mmHg, −160 mmHg,−180 mmHg, −200 mmHg, or below −200 mmHg. During intermittent therapy,negative pressure at low setpoint can be delivered for a first timeduration, and upon expiration of the first time duration, negativepressure at high setpoint can be delivered for a second time duration.Upon expiration of the second time duration, negative pressure at lowsetpoint can be delivered. The first and second time durations can besame or different values. The first and second durations can be selectedfrom the following range: less than 2 minutes, 2 minutes, 3 minutes, 4minutes, 6 minutes, 8 minutes, 10 minutes, or greater than 10 minutes.In some embodiments, switching between low and high setpoints and viceversa can be performed according to a step waveform, square waveform,sinusoidal waveform, and the like.

In operation, the wound filler 130 is inserted into the wound cavity 110and wound cover 120 is placed so as to seal the wound cavity 110. Thepump assembly 150 provides a source of a negative pressure to the woundcover 120, which is transmitted to the wound cavity 110 via the woundfiller 130. Fluid (e.g., wound exudate) is drawn through the conduit140, and can be stored in a canister. In some embodiments, fluid isabsorbed by the wound filler 130 or one or more absorbent layers (notshown).

Wound dressings that may be utilized with the pump assembly and otherembodiments of the present application include Renasys-F, Renasys-G,Renasys AB, and Pico Dressings available from Smith & Nephew. Furtherdescription of such wound dressings and other components of a negativepressure wound therapy system that may be used with the pump assemblyand other embodiments of the present application are found in U.S.Patent Publication Nos. 2011/0213287, 2011/0282309, 2012/0116334,2012/0136325, and 2013/0110058, which are incorporated by reference intheir entirety. In other embodiments, other suitable wound dressings canbe utilized.

Pump Assembly and Canister

FIG. 2A illustrates a front view 200A of a pump assembly 230, such asthe pump assembly 150, and canister 220 according to some embodiments.As is illustrated, the pump assembly 230 and the canister 220 areconnected, thereby forming a device. The pump assembly 230 comprises oneor more indicators, such as visual indicator 202 configured to indicatealarms and visual indicator 204 configured to indicate status of the TNPsystem. The indicators 202 and 204 can be configured to alert a user,such as patient or medical care provider, to a variety of operatingand/or failure conditions of the system, including alerting the user tonormal or proper operating conditions, pump failure, power supplied tothe pump or power failure, detection of a leak within the wound cover orflow pathway, suction blockage, or any other similar or suitableconditions or combinations thereof. The pump assembly 230 can compriseadditional indicators. The pump assembly can use a single indicator ormultiple indicators. Any suitable indicator can be used such as visual,audio, tactile indicator, and so on. The indicator 202 can be configuredto signal alarm conditions, such as canister full, power low, conduit140 disconnected, seal broken in the wound seal 120, and so on. Theindicator 202 can be configured to display red flashing light to draw auser's attention. The indicator 204 can be configured to signal statusof the TNP system, such as therapy delivery is ok, leak detected, and soon. The indicator 204 can be configured to display one or more differentcolors of light, such as green, yellow, etc. For example, green lightcan be emitted when the TNP system is operating properly and yellowlight can be emitted to indicate a warning.

The pump assembly 230 comprises a display or screen 206 mounted in arecess 208 formed in a case of the pump assembly. The display 206 can bea touchscreen display. The display 206 can support playback ofaudiovisual (AV) content, such as instructional videos. As explainedbelow, the display 206 can be configured to render a number of screensor graphical user interfaces (GUIs) for configuring, controlling, andmonitoring the operation of the TNP system. The pump assembly 230comprises a gripping portion 210 formed in the case of the pumpassembly. The gripping portion 210 can be configured to assist the userto hold the pump assembly 230, such as during removal of the canister220. The canister 220 can be replaced with another canister, such aswhen the canister 220 has been filled with fluid.

The pump assembly 230 comprises one or more keys or buttons 212configured to allow the user to operate and monitor the operation of theTNP system. As is illustrated, there buttons 212 a, 212 b, and 212 c areincluded. Button 212 a can be configured as a power button to turnon/off the pump assembly 230. Button 212 b can be configured as aplay/pause button for the delivery of negative pressure therapy. Forexample, pressing the button 212 b can cause therapy to start, andpressing the button 212 b afterward can cause therapy to pause or end.Button 212 c can be configured to lock the display 206 and/or thebuttons 212. For instance, button 212 c can be pressed so that the userdoes not unintentionally alter the delivery of the therapy. Button 212 ccan be depressed to unlock the controls. In other embodiments,additional buttons can be used or one or more of the illustrated buttons212 a, 212 b, or 212 c can be omitted. Multiple key presses and/orsequences of key presses can be used to operate the pump assembly 230.

The pump assembly 230 includes one or more latch recesses 222 formed inthe cover. In the illustrated embodiment, two latch recesses 222 can beformed on the sides of the pump assembly 230. The latch recesses 222 canbe configured to allow attachment and detachment of the canister 220using one or more canister latches 221. The pump assembly 230 comprisesan air outlet 224 for allowing air removed from the wound cavity 110 toescape. Air entering the pump assembly 230 can be passed through one ormore suitable filters, such as antibacterial filters. This can maintainreusability of the pump assembly 230. The pump assembly 230 includes oneor more strap mounts 226 for connecting a carry strap to the pumpassembly 230 or for attaching a cradle. In the illustrated embodiment,two strap mounts 226 can be formed on the sides of the pump assembly230. In some embodiments, various of these features are omitted and/orvarious additional features are added to the pump assembly 230.

The canister 220 is configured to hold fluid (e.g., exudate) removedfrom the wound cavity 110. The canister 220 includes one or more latches221 for attaching the canister to the pump assembly 230. In theillustrated embodiment, the canister 220 comprises two latches 221 onthe sides of the canister. The exterior of the canister 220 can formedfrom frosted plastic so that the canister is substantially opaque andthe contents of the canister and substantially hidden from plain view.The canister 220 comprises a gripping portion 214 formed in a case ofthe canister. The gripping portion 214 can be configured to allow theuser to hold the pump assembly 220, such as during removal of thecanister from the apparatus 230. The canister 220 includes asubstantially transparent window 216, which can also include graduationsof volume. For example, the illustrated 300 mL canister 220 includesgraduations of 50 mL, 100 mL, 150 mL, 200 mL, 250 mL, and 300 mL. Otherembodiments of the canister can hold different volume of fluid and caninclude different graduation scale. For example, the canister can be an800 mL canister. The canister 220 comprises a tubing channel 218 forconnecting to the conduit 140. In some embodiments, various of thesefeatures, such as the gripping portion 214, are omitted and/or variousadditional features are added to the canister 220. Any of the disclosedcanisters may include or may omit a solidifier.

FIG. 2B illustrates a rear view 200B of the pump assembly 230 andcanister 220 according to some embodiments. The pump assembly 230comprises a speaker port 232 for producing sound. The pump assembly 230includes a filter access door 234 for accessing and replacing one ormore filters, such as antibacterial filters. The pump assembly 230comprises a gripping portion 236 formed in the case of the pump assembly230. The gripping portion 236 can be configured to allow the user tohold the pump assembly 230, such as during removal of the canister 220.The pump assembly 230 includes one or more covers 238 configured to asscrew covers and/or feet or protectors for placing the pump assembly 230on a surface. The covers 230 can be formed out of rubber, silicone, orany other suitable material. The pump assembly 230 comprises a powerjack 239 for charging and recharging an internal battery of the pumpassembly. The power jack 239 can be a direct current (DC) jack. In someembodiments, the pump assembly 230 can comprise a disposable powersource, such as batteries, so that no power jack is needed.

The canister 220 includes one or more feet 244 for placing the canisteron a surface. The feet 244 can be formed out of rubber, silicone, or anyother suitable material and can be angled at a suitable angle so thatthe canister 220 remains stable when placed on the surface. The canister220 comprises a tube mount relief 246 configured to allow one or moretubes to exit to the front of the device. The canister 220 includes astand or kickstand 248 for supporting the canister when it is placed ona surface. As explained below, the kickstand 248 can pivot between anopened and closed position. In closed position, the kickstand 248 can belatched to the canister 220. In some embodiments, the kickstand 248 canbe made out of opaque material, such as plastic. In other embodiments,the kickstand 248 can be made out of transparent material. The kickstand248 includes a gripping portion 242 formed in the kickstand. Thegripping portion 242 can be configured to allow the user to place thekickstand 248 in the closed position. The kickstand 248 comprises a hole249 to allow the user to place the kickstand in the open position. Thehole 249 can be sized to allow the user to extend the kickstand using afinger.

FIG. 2C illustrates a view 200C of the pump assembly 230 separated fromthe canister 220 according to some embodiments. The pump assembly 230includes a vacuum attachment, connector, or inlet 252 through which avacuum pump communicates negative pressure to the canister 220. The pumpassembly aspirates fluid, such as gas, from the wound via the inlet 252.The pump assembly 230 comprises a USB access door 256 configured toallow access to one or more USB ports. In some embodiments, the USBaccess door is omitted and USB ports are accessed through the door 234.The pump assembly 230 can include additional access doors configured toallow access to additional serial, parallel, and/or hybrid data transferinterfaces, such as SD, Compact Disc (CD), DVD, FireWire, Thunderbolt,PCI Express, and the like. In other embodiments, one or more of theseadditional ports are accessed through the door 234.

Additional description of the pump assembly 230 is disclosed in U.S.patent application Ser. No. 14/210,062, filed on Mar. 13, 2014 andtitled “SYSTEMS AND METHODS FOR APPLYING REDUCED PRESSURE THERAPY,”which is incorporated by reference in its entirety.

Electronics and Software

FIG. 3 illustrates an electrical component schematic 300 of a pumpassembly, such as the pump assembly 150, according to some embodiments.Electrical components can operate to accept user input, provide outputto the user, operate the pump assembly and the TNP system, providenetwork connectivity, and so on. Electrical components can be mounted onone or more printed circuit boards (PCBs). As is illustrated, the pumpassembly can include multiple processors. It may be advantageous toutilize multiple processors in order to allocate or assign various tasksto different processors. A first processor can be responsible for useractivity and a second processor can be responsible for controlling thepump. This way, the activity of controlling the pump, which maynecessitate a higher level of responsiveness (corresponding to higherrisk level), can be offloaded to a dedicated processor and, thereby,will not be interrupted by user interface tasks, which may take longerto complete because of interactions with the user.

The pump assembly can comprise a user interface processor or controller310 configured to operate one or more components for accepting userinput and providing output to the user, such as the display 206, buttons212, etc. Input to the pump assembly and output from the pump assemblycan controlled by an input/output (I/O) module 320. For example, the I/Omodule can receive data from one or more ports, such as serial,parallel, hybrid ports, and the like. The processor 310 also receivesdata from and provides data to one or more expansion modules 360, suchas one or more USB ports, SD ports, Compact Disc (CD) drives, DVDdrives, FireWire ports, Thunderbolt ports, PCI Express ports, and thelike. The processor 310, along with other controllers or processors,stores data in one or more memory modules 350, which can be internaland/or external to the processor 310. Any suitable type of memory can beused, including volatile and/or non-volatile memory, such as RAM, ROM,magnetic memory, solid-state memory, Magnetoresistive random-accessmemory (MRAM), and the like.

In some embodiments, the processor 310 can be a general purposecontroller, such as a low-power processor. In other embodiments, theprocessor 310 can be an application specific processor. The processor310 can be configured as a “central” processor in the electronicarchitecture of the pump assembly, and the processor 310 can coordinatethe activity of other processors, such as a pump control processor 370,communications processor 330, and one or more additional processors 380(e.g., processor for controlling the display 206, processor forcontrolling the buttons 212, etc.). The processor 310 can run a suitableoperating system, such as a Linux, Windows CE, VxWorks, etc.

The pump control processor 370 can be configured to control theoperation of a negative pressure pump 390. The pump 390 can be asuitable pump, such as a diaphragm pump, peristaltic pump, rotary pump,rotary vane pump, scroll pump, screw pump, liquid ring pump, diaphragmpump operated by a piezoelectric transducer, voice coil pump, and thelike. The pump can include one or more valves, such as inlet and outlet(or exhaust) valves. The valves can be configured to open and close toenable the pump to aspirate fluid from the wound cavity 110. The pumpcontrol processor 370 can measure pressure in a fluid flow path, usingdata received from one or more pressure sensors, calculate the rate offluid flow, and control the pump. The pump control processor 370 cancontrol a pump motor so that a desired level of negative pressure isachieved in the wound cavity 110. The desired level of negative pressurecan be pressure set or selected by the user. In various embodiments, thepump control processor 370 controls the pump (e.g., pump motor) usingpulse-width modulation (PWM). A control signal for driving the pump canbe a 0-100% duty cycle PWM signal. The pump control processor 370 canperform flow rate calculations and detect various conditions in a flowpath. The pump control processor 370 can communicate information to theprocessor 310. The pump control processor 370 can include internalmemory and/or can utilize memory 350. The pump control processor 370 canbe a low-power processor. In some embodiments, processor 310 isconfigured to control the pump 390, and pump control processor 370 isnot used.

A communications processor 330 can be configured to provide wired and/orwireless connectivity. The communications processor 330 can utilize oneor more antennas 340 for sending and receiving data. The communicationsprocessor 330 can provide one or more of the following types ofconnections: Global Positioning System (GPS) technology, cellularconnectivity (e.g., 2G, 3G, LTE, 4G), WiFi connectivity, Internetconnectivity, and the like. Connectivity can be used for variousactivities, such as pump assembly location tracking, asset tracking,compliance monitoring, remote selection, uploading of logs, alarms, andother operational data, and adjustment of therapy settings, upgrading ofsoftware and/or firmware, and the like. The communications processor 330can provide dual GPS/cellular functionality. Cellular functionality can,for example, be 3G functionality. In such cases, if the GPS module isnot able to establish satellite connection due to various factorsincluding atmospheric conditions, building or terrain interference,satellite geometry, and so on, the device location can be determinedusing the 3G network connection, such as by using cell identification,triangulation, forward link timing, and the like. The pump assembly caninclude a SIM card, and SIM-based positional information can beobtained.

The communications processor 330 can communicate information to theprocessor 310. The communications processor 330 can include internalmemory and/or can utilize memory 350. The communications processor 330can be a low-power processor.

In some embodiments, the pump assembly can track and store various data,such as one or more of positioning data, therapy parameters, logs,device data, and so on. The pump assembly can track and log therapy andother operational data. Data can be stored, for example, in the memory350. The frequency or triggering of tracking or storing the various datacan moreover vary depending on one or more conditions. For example, thevarious data (e.g., positioning data for a pump assembly) can be trackedor stored periodically, such as once per day, hour, or minute, or withmore or less frequency. As another example, the various data (e.g.,positioning data for a pump assembly) can be tracked or stored when thepump assembly changes its mode of operation (e.g., initiates or stopsproviding therapy), connects to a communications network (e.g., 3G orWiFi network) using the communications processor 330, and the like. Suchfrequency or triggering control can, in certain embodiments,advantageously enable protection of the privacy of users of the pumpassembly such that limited information about the use or possession ofthe pump assembly are tracked or stored.

In some embodiments, using the connectivity provided by thecommunications processor 330, the device can upload any of the datastored, maintained, and/or tracked by the pump assembly. For example,the following information can be uploaded to a remote computer orserver: activity log(s), which includes therapy delivery information,such as therapy duration, alarm log(s), which includes alarm type andtime of occurrence; error log, which includes internal errorinformation, transmission errors, and the like; therapy durationinformation, which can be computed hourly, daily, and the like; totaltherapy time, which includes therapy duration from first applying aparticular therapy program or programs; lifetime therapy information;device information, such as the serial number, software version, batterylevel, etc.; device location information; patient information; and soon. The device can also download various operational data, such astherapy selection and parameters, firmware and software patches andupgrades, and the like. The pump assembly can provide Internet browsingfunctionality using one or more browser programs, mail programs,application software (e.g., apps), etc.

In some embodiments, the communications processor 330 can use theantenna 340 to communicate a location of the pump assembly, such as alocation of a housing of the pump assembly, to other devices in theproximity (for example, within 10, 20, or 50 meters and the like) of thepump assembly. The communications processor 330 can perform one-way ortwo-way communication with the other devices depending on theimplementation. The communications transmitted by the communicationsprocessor 330 can include identifying information to uniquely identifythe pump assembly relative to one or more other pump assemblies also inthe proximity of the pump assembly. For example, identifying informationcan include a serial number or a value derived from the serial number.The signal strength of the transmitted communications by thecommunications processor 330 can be controlled (for example, maintainedat a constant or substantially constant level) to enable another deviceto determine a distance to the pump assembly, such as a distance betweenthe device and the pump assembly.

In some embodiments, the communications processor 330 can communicatewith other devices in the proximity of the pump assembly so that thecommunications processor 330 can itself determine a distance from thepump assembly to the other devices. The communications processor 330, insuch embodiments, can track and store the distance from the pumpassembly to the other devices or indications of change in the distanceover time, and the communications processor 330 can later provide thisinformation to the other devices. For instance, the communicationsprocessor 330 can determine a duration of time during which the pumpassembly has been removed from a coverage area of a device andsubsequently report this time to the device upon being returned to thecoverage area.

FIG. 4 illustrates a system schematic 400 according to some embodiments.A pump assembly 420, such as the pump assembly 150, includes a userinterface processor firmware and/or software 422, which can be executedby the user interface processor 310, pump control processor firmwareand/or software 424, which can be executed by the pump control processor370, communications processor firmware and/or software 426, which can beexecuted by the communications processor 330, and additionalprocessor(s) firmware and/or software 428, which can be executed by oneor more additional processors 380. The pump assembly 420 can beconnected to a user computer 410, which can be a laptop, desktop,tablet, smartphone, and the like. A wired or wireless connection can beutilized to connect the computer 410 to the pump assembly 420. Forexample, a USB connection can be used. The connection between thecomputer 410 and the pump assembly 420 can be used for variousactivities, such as pump assembly location tracking, asset tracking,compliance monitoring, selection, uploading of logs, alarms, and otheroperational data, and adjustment of therapy settings, upgrading ofsoftware and/or firmware, and the like. The pump assembly 420 andcomputer 410 can communicate with a remote computer or server 440 viathe cloud 430. As is used herein, the term “cloud” and the like, inaddition to having its ordinary meaning, can refer to the Internet. Theremote computer 440 can include a data storage module 442 and a webinterface 444 for accessing the remote computer 440. The remote computer440 includes a processor 446, such as one or more CPUs. In someembodiments, the remote computer 440 includes multiple computers.

The connection between the computer 410 and pump assembly 420 can beutilized to perform one or more of the following: initialization andprogramming of the pump assembly 420, firmware and/or software upgrades,maintenance and troubleshooting, selecting and adjusting therapyparameters, and the like. In some embodiments, the computer 410 canexecute an application program for communicating the pump assembly 420.

The pump assembly 420 can upload various data to the remote computer (ormultiple remote computers) 440 via the cloud 430. As explained above,upload data can include activity log(s), alarm log(s), therapy durationinformation, total therapy time, lifetime therapy information, deviceinformation, device location information, patient information, etc. Inaddition, the pump assembly 420 can receive and process commandsreceived from the cloud 430.

In some embodiments, the frequency or triggering of uploading variousdata by the pump assembly can moreover vary depending on one or moreconditions. In one example, the various data can be uploaded with afrequency that depends on whether an external power source is connectedto the pump assembly (e.g., the various data can be uploaded morefrequently when connected to line or mains power than when not connectedto mains power) and/or certain power settings for the pump assembly(e.g., the various data can be uploaded less frequently when powersettings indicate a lower power mode of operation for the pumpassembly). For instance, the pump assembly can upload positioning data(i) once per hour when the pump assembly is connected to mains power andwhen a backlight of the touchscreen is on indicating a higher power modeof operation for the pump assembly and (ii) once per two hours when thepump assembly is not connected to mains power (e.g., pump assembly isrunning off battery power) or when the backlight of the touchscreen isoff indicating a lower power mode of operation for the pump assembly. Inanother example, the various data may be uploaded when a communicationsnetwork connection is enabled for the pump assembly or when the pumpassembly is connected to a communications network, but not whencommunications network connection is disabled or when the pump assemblyis not connected to the communications network. In yet another example,the powering on or off of the pump assembly can trigger the transmissionof the various data, potentially with a delay in some implementations(e.g., data transmission can be triggered ten minutes after power on ofa pump assembly if more than one hour has elapsed since a last power offof the pump assembly). In a further example, when data is loaded to thepump assembly (e.g., via the I/O module 320, expansion module 360, etc.)rather than collected by the pump assembly (e.g., as a result of theprovision of therapy by the pump assembly), the transmission of thevarious data, such as the data loaded to the pump assembly, can betriggered.

In some embodiments, the computer 410 can be used to create an accountwith the remote computer 440 and register one or more pump assemblies tothe account. The computer 410 can then, for example, be used to login tothe account to access saved therapy data for the one or more registeredpump assemblies, access operation instructions for the one or moreregistered pump assemblies, enable or control certain functionality ofthe one or more registered pump assemblies, and the like. Theregistration process can additionally enable possession or usage of theone or more registered pump assemblies to be attributed to an accountowner so that any restrictions on use (e.g., use limited to specificentities, within geographic areas, or under certain contractual terms)for the one or more pump assemblies may be tracked or enforced.

Operation of the Pump Assembly

In some embodiments, the pump assembly 230 can be operated using atouchscreen interface displayed on the screen 206. Various graphicaluser interface (GUI) screens present information on systems settings andoperations, among other things. The touchscreen interface can beactuated or operated by a finger (or a stylus or another suitabledevice). Tapping a touchscreen cam result in making a selection. Toscroll, a user can touchscreen and hold and drag to view the selections.Additional or alternative ways to operate the touchscreen interface canbe implemented, such as multiple finger swipes for scrolling, multiplefinger pinch for zooming, and the like.

FIGS. 5A-5C illustrate graphical user interface screens according tosome embodiments. The GUI screens can be displayed on the screen 206,which can be configured as a touchscreen interface. Informationdisplayed on the screens can be generated based on input received fromthe user. The GUI screens can be utilized for initializing the device,selecting and adjusting therapy settings, monitoring device operation,uploading data to the network (e.g., cloud), and the like. Theillustrated GUI screens can be generated directly by an operating systemrunning on the processor 310 and/or by a graphical user interface layeror component running on the operating system. For instance, the screenscan be developed using Qt framework available from Digia.

FIG. 5A illustrates a therapy settings screen 500A according to someembodiments. The therapy settings screen 500A can be displayed after thepump assembly has been initialized (e.g., screen 500A can function as ahome screen). The therapy settings screen 500A includes a status bar 502that comprises icons indicating operational parameters of the device.Animated icon 503 is a therapy delivery indicator. When therapy is notbeing delivered, icon 503 can be static and displayed in a color, suchas gray. When therapy is being delivered, icon 503 can turn a differentcolor, such as orange, and becomes animated, such as, rotates, pulsates,become filled with color, etc. Other status bar icons include a volumeindicator and a battery indicator, and may include additional icons,such as wireless connectivity. The therapy settings screen 500A includesdate/time and information. The therapy settings screen 500A includes amenu 510 that comprises menu items 512 for accessing device settings,514 for accessing logs, 516 for accessing help, and 518 for returning tothe therapy settings screen (or home screen) from other screens. Thepump assembly can be configured so that after a period of inactivity,such as not receiving input from the user, therapy settings screen 500A(or home screen) is displayed. Additional or alternative controls,indicators, messages, icons, and the like can be used.

The therapy settings screen 500A includes negative pressure up and downcontrols 522 and 524. Up and down controls 522 and 524 can be configuredto adjust the negative pressure setpoint by a suitable step size, suchas ±5 mmHg. As is indicated by label 526, the current therapy selectionis −80 mmHg (or 80 mmHg below atmospheric pressure). The therapysettings screen 500A includes continuous/intermittent therapy selection530. Continuous therapy selection screen can be accessed via control 532and intermittent therapy selection screen can be accessed via control534. As is illustrated, the current therapy setting is to continuouslydeliver negative pressure at −80 mmHg. As is indicated by message 528,therapy delivery can be initiated by pressing a button, such as button212 b on the pump assembly 230. The therapy settings screen 500Aincludes Y-connector selection 535 for treating multiple wounds, such astwo, three, etc. wounds, with one pump assembly 230. Control 536 selectstreatment of a single wound, and control 538 selects treatment of morethan one wound by the pump assembly. As is indicated by the label“Y-CONNECT OFF,” the current selection is to treat a single wound.Additional or alternative controls, indicators, messages, icons, and thelike can be used.

FIG. 5B illustrates settings screen 500B according to some embodiments.The settings screen 500B can be accessed by selecting menu item 512(e.g., from screen 500A). As is illustrated, settings screen 500Bincludes a menu 560 for adjusting various operational parameters of thepump assembly 230, including alarm volume setting, compression setting562, user mode setting (e.g., clinician or patient), language setting,time zone setting, flow meter 564, restore presets (e.g., factorypresets), and device information. Attempting to set the user mode asclinician mode may prompt the user to enter a password or satisfy anyother suitable security check. Operating the pump assembly in clinicianmode can provide unrestricted access to all features and settings,whereas operating the pump assembly in patient mode can preventinadvertent changes to therapy settings by preventing access to one ormore features and settings, such as therapy settings, compressionsettings, and the like. Alternative or additional menu items can bedisplayed. The illustrated menu 560 is an expanded version of the menushowing all menu items. In use, menu 560 may only partially fit on thescreen, and the menu items can be accessed via the scroll bar 561 or viaany other suitable alternative or additional controls. Additional oralternative controls, indicators, messages, icons, and the like can beused.

FIG. 5C illustrates alarms and troubleshooting screen 500C according tosome embodiments. The screen 500C can be accessed by selecting the menuitem 516 for accessing help (see FIG. 5B) and selecting alarms menu itemfrom the help screen (not shown). As is illustrated, screen 5000includes a menu 588 with menu items for various alarm andtroubleshooting categories, including over vacuum, high vacuum,blockage, canister flow, high flow/leak, and low or insufficient vacuum(as explained below) as well as technical failure (e.g., unrecoverableerror), battery (e.g., low battery, critical low battery, batteryfailed), and inactivity (e.g., pump assembly is powered on an has beenleft without user interaction for longer than a certain period of time,such as 15 minutes). Alternative or additional menu items can bedisplayed. Accessing a particular menu item can bring up a screen withstep-by-step instructions to assist in resolving the correspondingalarm. The instructions can include a combination of text, audio, video,etc. The illustrated menu 588 is an expanded version of the menu showingall menu items. In use, menu 588 may only partially fit on the screen,and menu items can be accessed via the scroll bar 587 or via any othersuitable alternative or additional controls. Additional or alternativecontrols, indicators, messages, icons, and the like can be used.

Pump Assembly Registration and Usage Validation

FIG. 6 illustrates a process 600 for validating the registration andusage of a pump assembly, such as the pump assembly 150, with a remoteserver according to some embodiments. The process 600 can be executed,for example, by the remote computer 440. Advantageously, the process 600can, in certain embodiments, enable the remote computer 440 to determineor track unauthorized registration and uses of a pump assembly and takeappropriate actions (e.g., automatically generating a notificationmessage or adjusting operation of the pump assembly). Although theprocess 600 is described as being performed for one pump assembly forconvenience, the process 600 can be performed for tens, hundreds,thousands, or more pump assemblies.

The process 600 begins at block 602 when a registration request isreceived for a pump assembly, such as the pump assembly 150, to registerthe pump assembly to an account. The registration request can bereceived from a computer, such as the computer 410 or the pump assembly,such as the pump assembly 420, via a communications network, such as thecloud 430. The registration request can indicate to register the pumpassembly with an account so that the pump assembly becomes associatedwith the account in the future. The account can be a user account orentity account in account information managed by the remote computer 440and through which a patient, caregiver, or another individual or entitycan access information gathered by the remote computer 440 related tothe registered pump assembly (e.g., activity log(s), alarm log(s),therapy duration information, total therapy time, or lifetime therapyinformation for the registered pump assembly). One account can beregistered with one or more different pump assemblies (e.g., a fleet),and one pump assembly can be registered to one or more differentaccounts.

At block 604, the process 600 can determine whether the pump assembly isauthorized to be registered to the account. In one example, the process600 can use a data structure (e.g., a look-up table) including accountidentifiers and device identifiers to determine whether an accountidentifier for the account and a device identifier for the pump assemblyindicate that the pump assembly is authorized to be registered to theaccount. Other approaches for determining whether the pump assembly isauthorized to be registered to the account can be used in otherimplementations. Pump assembly may not be authorized to be registeredwhen it is determined that the user or entity associated with theaccount is not permitted to administer or be associated with the pumpassembly. In response to determining that the pump assembly isunauthorized to be registered to the account, the process 600 moves toblock 606.

At block 606, the process 600 performs an exception action for the pumpassembly or account. The exception action can, in one example, includegenerating and sending a notification communication (e.g., an email,SMS, etc.) to an owner of the account or an administrator of a group(e.g., accounts within a geographic area) that includes the accountinforming of the exception. The notification communication can inform areceipt about the unauthorized registration attempt and/or providesuggested actions for resolving issues associated with the unauthorizedregistration (e.g., offering information about what steps may be takenso that the pump assembly may be successfully registered). In anotherexample, the exception action can include preventing registration of thepump assembly to the account and/or enabling the registration to remainin effect for a limited duration (e.g., one week). In yet otherexamples, the exception action can include one or more of the following:(i) generating and sending a command message to the pump assemblylimiting the operation capabilities for the pump assembly (e.g.,disabling certain components or features, shortening the useful life,altering modes of operation, or changing data gathering approaches),(ii) generating and sending a command message to the pump assemblycausing the pump assembly to provide its location (e.g., GPS locationincluding longitude and latitude coordinates) more frequently to theremote computer 440, (iii) generating and sending a command message tothe pump assembly causing the pump assembly to display a notification onthe screen that the pump assembly is not properly registered (e.g., thenotification may be display periodically or consistently until the pumpassembly may be successfully registered), (iv) initiating theinstallation of revised operating or calibration software on the pumpassembly, or (v) generating and sending a command message to the pumpassembly causing the power of the pump assembly to cycle off and on.After block 606, the process 600 ends.

On the other hand, in response to determining that the pump assembly isauthorized to be registered to the account, the process 600 moves toblock 608, and the pump assembly is registered to the account. Afterregistration, the owner of the account may login to the account toaccess the information gathered by the remote computer 440 related tothe pump assembly, such as information communicated (e.g., uploaded) bythe pump assembly.

At block 610, the process 600 receives a pump assembly usagenotification. The pump assembly usage notification can be acommunication (e.g., data upload) indicating that the pump assembly hasbeen turned on or that one or more other operations have been performedby the pump assembly. The pump assembly usage notification can becommunicated by the pump assembly or a computer, such as the computer410, via a communications network, such as the cloud 430. The pumpassembly usage notification can include an indication of a location ofthe pump assembly (e.g., a current location of the pump assembly or alocation of the pump assembly when the pump assembly was turned on), aswell as how, when, or for what duration the pump assembly is or wasused. The indication of the location can include information such as aGPS location of the pump assembly.

At block 612, the process 600 determines whether the pump assembly is inan authorized location. The process 600 can, for instance, compare theindication of the location from the pump assembly usage notificationwith a permitted zone of usage for the pump assembly, such as a zonedefined by terms associated with administration of the pump assembly andstored in a memory (e.g., a memory of the remote computer 440). This canbe performed using a data structure (e.g., a look-up table) includingdevice identifiers and location identifiers to determine whether adevice identifier for the pump assembly and a location identifier forthe location indicate that the pump assembly is or was in an authorizedlocation. Other approaches for determining whether the pump assembly isin an authorized location can be used in other implementations.

In response to determining that the pump assembly is in an unauthorizedlocation, the process 600 moves to block 606 and performs an exceptionaction, such as described herein, for the pump assembly or account. Forexample, the exception action can include generating and sending anotification communication (e.g., an email, SMS, etc.) to an owner of anaccount or an administrator of a group (e.g., accounts within ageographic area) to which the pump assembly is registered or associated.The notification communication can inform a receipt about theunauthorized location for the pump assembly and/or provide suggestedactions for resolving issues associated with the unauthorized location(e.g., offering information about where the pump assembly is authorizedto be used or what steps may be taken so that the location in which thepump assembly may be used can be adjusted or expanded to cover theunauthorized location).

On the other hand, in response to determining that the pump assembly isin an authorized location, the process 600 moves to block 614. At block614, the process 600 determines whether a usage of the pump assembly isauthorized. The process 600, for instance, can compare the indication ofhow, when, or for what duration the pump assembly is or was used with anauthorized usage for the pump assembly, such as a usage defined by theterms associated with usage of the pump assembly and stored in a memory(e.g., a memory of the remote computer 440). This can be performed usinga data structure (e.g., a look-up table) including device identifiersand operation identifiers to determine whether a device identifier forthe pump assembly and an operation identifier for an operation performedby the pump assembly indicate that the pump assembly is or was used in apermitted manner. Other approaches for determining whether the usage ofthe pump assembly is authorized can be utilized in otherimplementations.

In response to determining that the usage of the pump assembly isunauthorized, the process 600 moves to block 606 and performs anexception action, such as described herein, for the pump assembly oraccount. For example, the exception action can include generating andsending a notification communication (e.g., an email, SMS, etc.) to anowner of an account or an administrator of a group (e.g., accountswithin a geographic area) to which the pump assembly is registered orassociated. The notification communication can inform a receipt aboutthe unauthorized usage for the pump assembly and/or provide suggestedactions for resolving issues associated with the unauthorized usagee.g., offering information about how the pump assembly may be properlyused or what steps may be taken so that the pump assembly usageabilities for the pump assembly may be adjusted or expanded to cover theunauthorized usage). On the other hand, in response to determining thatthe usage of the pump assembly is authorized, the process 600 moves toblock 616.

At block 616, the process 600 stores an indication of the authorizedusage of the assembly to the account to which the pump assembly isregistered. The process 600 can, for example, store to a memory (e.g., amemory of the remote computer 440) the indication of a duration of theauthorized usage of the pump assembly in association with the account sothat the duration of the authorized usage is later available for accessvia the account.

In some embodiments, the process 600 can be used or modified to trackarrival of one or more pump assemblies at one or more particularlocations, such as one or more hospitals, care facilities, and the like.For example, at block 610, the indication of the location for a pumpassembly can be received and, based at least on the indication of thelocation, arrival of the pump assembly can be tracked. In variousembodiments, the process 600 can be used or modified to track misplacedor lost pump assemblies. For example, the indication of the location fora pump assembly received at block 610 can be used to determine thelocation of a misplaced pump assembly.

Other Variations

Any value of a threshold, limit, duration, etc. provided herein is notintended to be absolute and, thereby, can be approximate. In addition,any threshold, limit, duration, etc. provided herein can be fixed orvaried either automatically or by a user. Furthermore, as is used hereinrelative terminology such as exceeds, greater than, less than, etc. inrelation to a reference value is intended to also encompass being equalto the reference value. For example, exceeding a reference value that ispositive can encompass being equal to or greater than the referencevalue. In addition, as is used herein relative terminology such asexceeds, greater than, less than, etc. in relation to a reference valueis intended to also encompass an inverse of the disclosed relationship,such as below, less than, greater than, etc. in relations to thereference value.

Features, materials, characteristics, or groups described in conjunctionwith a particular aspect, embodiment, or example are to be understood tobe applicable to any other aspect, embodiment or example describedherein unless incompatible therewith. All of the features disclosed inthis specification (including any accompanying claims, abstract anddrawings), and/or all of the steps of any method or process sodisclosed, may be combined in any combination, except combinations whereat least some of such features and/or steps are mutually exclusive. Theprotection is not restricted to the details of any foregoingembodiments. The protection extends to any novel one, or any novelcombination, of the features disclosed in this specification (includingany accompanying claims, abstract and drawings), or to any novel one, orany novel combination, of the steps of any method or process sodisclosed.

While certain embodiments have been described, these embodiments havebeen presented by way of example only, and are not intended to limit thescope of protection. Indeed, the novel methods and systems describedherein may be embodied in a variety of other forms. Furthermore, variousomissions, substitutions and changes in the form of the methods andsystems described herein may be made. Those skilled in the art willappreciate that in some embodiments, the actual steps taken in theprocesses illustrated and/or disclosed may differ from those shown inthe figures. Depending on the embodiment, certain of the steps describedabove may be removed, others may be added. For example, the actual stepsand/or order of steps taken in the disclosed processes may differ fromthose shown in the figure. Depending on the embodiment, certain of thesteps described above may be removed, others may be added. For instance,the various components illustrated in the figures may be implemented assoftware and/or firmware on a processor, controller, ASIC, FPGA, and/ordedicated hardware. Hardware components, such as processors, ASICs,FPGAs, and the like, can include logic circuitry. Furthermore, thefeatures and attributes of the specific embodiments disclosed above maybe combined in different ways to form additional embodiments, all ofwhich fall within the scope of the present disclosure.

User interface screens illustrated and described herein can includeadditional and/or alternative components. These components can includemenus, lists, buttons, text boxes, labels, radio buttons, scroll bars,sliders, checkboxes, combo boxes, status bars, dialog boxes, windows,and the like. User interface screens can include additional and/oralternative information. Components can be arranged, grouped, displayedin any suitable order.

Although the present disclosure includes certain embodiments, examplesand applications, it will be understood by those skilled in the art thatthe present disclosure extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses and obviousmodifications and equivalents thereof, including embodiments which donot provide all of the features and advantages set forth herein.Accordingly, the scope of the present disclosure is not intended to belimited by the specific disclosures of preferred embodiments herein, andmay be defined by claims as presented herein or as presented in thefuture.

What is claimed is:
 1. An apparatus for processing registration andusage information for a plurality of negative pressure wound therapydevices, the apparatus comprising: a memory device configured to storeaccount information for a plurality of negative pressure wound therapydevices; and a computer system comprising computer hardware incommunication with the memory device, the computer system configured to:receive first and second registration requests to register first andsecond negative pressure wound therapy devices of the plurality ofnegative pressure wound therapy devices to an account in the accountinformation, the account associated with a user; determine, based atleast on the first and second registration requests, whether the firstand second negative pressure wound therapy devices are authorized to beregistered to the account; in response to determining that at least oneof the first or second negative pressure wound therapy devices is notauthorized to be registered to the account, perform a first exceptionaction; in response to determining that the first and second negativepressure wound therapy devices are authorized to be registered to theaccount, register the first and second negative pressure wound therapydevices to the account so that data gathered by the computer systemabout operations of the first and second negative pressure wound therapydevices is accessible via the account; receive a first usagenotification for the first negative pressure wound therapy device and asecond usage notification for the second negative pressure wound therapydevice, the first usage notification indicating a first location of thefirst negative pressure wound therapy device and a first operationperformed by the first negative pressure wound therapy device, and thesecond usage notification indicating a second location of the secondnegative pressure wound therapy device and a second operation performedby the second negative pressure wound therapy device; determine, basedat least on a comparison of the first location to a first locationidentifier corresponding to an authorized location and a comparison ofthe first operation performed by the first negative pressure woundtherapy device to a first operation identifier corresponding to anauthorized operation, whether the first negative pressure wound therapydevice is being operated at the authorized location and whether thefirst operation performed by the first negative pressure wound therapydevice is the authorized operation; determine, based at least on acomparison of the second location to the first location identifiercorresponding to the authorized location and a comparison of the secondoperation performed by the second negative pressure wound therapy deviceto the first operation identifier corresponding to the authorizedoperation, whether the second negative pressure wound therapy device isbeing operated at the authorized location and whether the secondoperation performed by the second negative pressure wound therapy deviceis the authorized operation; in response to determining that the firstnegative pressure wound therapy device is operated in a first differentlocation from the authorized location or that the first operationperformed by the first negative pressure wound therapy device is not theauthorized operation, perform a second exception action; in response todetermining that the first negative pressure wound therapy device isoperated in the authorized location and the first operation performed bythe first negative pressure wound therapy device is the authorizedoperation, store in the memory device a first indication of performanceof the first operation by the first negative pressure wound therapydevice to the account; in response to determining that the secondnegative pressure wound therapy device is operated in a second differentlocation from the authorized location or that the second operationperformed by the second negative pressure wound therapy device is notthe authorized operation, perform the second exception action; and inresponse to determining that the second negative pressure wound therapydevice is operated in the authorized location and the second operationperformed by the second negative pressure wound therapy device is theauthorized operation, store in the memory device a second indication ofperformance of the second operation by the second negative pressurewound therapy device to the account.
 2. The apparatus of claim 1,wherein the computer system is configured to receive the first andsecond registration requests comprising a first account identifiercorresponding to the account, a first device identifier corresponding tothe first negative pressure wound therapy device, and a second deviceidentifier corresponding to the second negative pressure wound therapydevice.
 3. The apparatus of claim 2, wherein the computer system isconfigured to use a look-up table comprising account identifiers anddevice identifiers to determine at least one of: whether the firstnegative pressure wound therapy device is authorized to be registered tothe account, the account identifiers comprising the first accountidentifier and the device identifiers comprising the first deviceidentifier, or whether the second negative pressure wound therapy deviceis authorized to be registered to the account, the account identifierscomprising the first account identifier and the device identifierscomprising the second device identifier.
 4. The apparatus of claim 1,wherein the first exception action comprises generation and transmissionof a notification communication to an owner of the account or anadministrator of a group that includes the account, the notificationcommunication indicating that at least one of the first or secondnegative pressure wound therapy device was attempted to be registered tothe account and that at least one of the first or second negativepressure wound therapy device is unauthorized to be registered to theaccount.
 5. The apparatus of claim 1, wherein the first exception actioncomprises at least one of: generation and transmission of a firstcommand message to the first negative pressure wound therapy device, thefirst command message instructing the first negative pressure woundtherapy device not to perform one or more operations, or generation andtransmission of a second command message to the second negative pressurewound therapy device, the second command message instructing the secondnegative pressure wound therapy device not to perform one or moreoperations.
 6. The apparatus of claim 1, wherein the computer system isconfigured to at least one of: receive the first usage notification fromthe first negative pressure wound therapy device, the first usagenotification providing the first location as a first Global PositioningSystem (GPS) location, or receive the second usage notification from thesecond negative pressure wound therapy device, the second usagenotification providing the second location as a second GlobalPositioning System (GPS) location.
 7. The apparatus of claim 1, whereinthe computer system is configured to use a look-up table comprisingdevice identifiers and location identifiers to determine at least oneof: whether the first negative pressure wound therapy device is operatedat the authorized location, the device identifiers comprising a firstdevice identifier corresponding to the first negative pressure woundtherapy device and the location identifiers comprising the firstlocation identifier, or whether the second negative pressure woundtherapy device is operated at the authorized location, the deviceidentifiers comprising a second device identifier corresponding to thesecond negative pressure wound therapy device and the locationidentifiers comprising the first location identifier.
 8. The apparatusof claim 1, wherein the computer system is configured to use a look-uptable comprising device identifiers and operation identifiers todetermine at least one of: whether the first operation performed by thefirst negative pressure wound therapy device is the authorizedoperation, the device identifiers comprising a first device identifiercorresponding to the first negative pressure wound therapy device andthe operation identifiers comprising the first operation identifier, orwhether the second operation performed by the second negative pressurewound therapy device is the authorized operation, the device identifierscomprising a second device identifier corresponding to the secondnegative pressure wound therapy device and the operation identifierscomprising the first operation identifier.
 9. The apparatus of claim 1,wherein the second exception action comprises at least one of:generation and transmission of a first notification communication to anowner of the account or an administrator of a group that includes theaccount, the first notification communication indicating that the firstnegative pressure wound therapy device is operated outside of theauthorized location, or generation and transmission of a secondnotification communication to the owner of the account or theadministrator of the group that includes the account, the secondnotification communication indicating that the second negative pressurewound therapy device is operated outside of the authorized location. 10.The apparatus of claim 1, wherein the second exception action comprisesat least one of: generation and transmission of a first notificationcommunication to an owner of the account or an administrator of a groupthat includes the account, the first notification communicationindicating that the first negative pressure wound therapy deviceperformed a first unauthorized operation, or generation and transmissionof a second notification communication to the owner of the account orthe administrator of the group that includes the account, the secondnotification communication indicating that the second negative pressurewound therapy device performed a second unauthorized operation.
 11. Theapparatus of claim 1, wherein the second exception action comprises atleast one of: generation and transmission of a first command message tothe first negative pressure wound therapy device, the first commandmessage instructing the first negative pressure wound therapy device notto perform one or more operations, or generation and transmission of asecond command message to the second negative pressure wound therapydevice, the second command message instructing the second negativepressure wound therapy device not to perform one or more operations. 12.The apparatus of claim 1, wherein the first exception action is the sameas the second exception action.
 13. The apparatus of claim 1, whereinthe computer system is configured to at least one of: receive the firstusage notification from the first negative pressure wound therapydevice, the first usage notification providing the first location as afirst cellular network location, or receive the second usagenotification from the second negative pressure wound therapy device, thesecond usage notification providing the second location as a secondcellular network location.
 14. The apparatus of claim 13, wherein thecomputer system is configured to at least one of: receive the firstusage notification providing the first location as the first cellularnetwork location responsive to a first Global Positioning System (GPS)location of the first negative pressure wound therapy device beingunavailable, or receive the second usage notification providing thesecond location as the second cellular network location responsive to asecond Global Positioning System (GPS) location of the second negativepressure wound therapy device being unavailable.